2026 data FDA MAUDE openFDA FDA Class II

Bed, Pediatric Open Hospital

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

OpenFDA device adverse-event casebook.

FDA Class II (moderate risk, special controls required), regulated under 21 CFR §880.5140 (General Hospital panel).

FDA MAUDE casebook

openFDA event book Bed, Pediatric Open Hospital LIGHT-BOOK · MAUDE

#610 of 1000 · 1,272 reports · 1993–2026

  • BOOK 1,272 reports
  • RANK #610 of 1000
  • DEATH 2 death-typed
  • INJ 36 injury-typed
  • MALF 1,196 malfunction
  • SPAN 1993–2026
  • PEAK 2015: 175
  • PHOTO Bone Mill

Nearest event-volume peer: Bone Mill (1 report gap)

Bed, Pediatric Open Hospital sits #610 of 1000 among tracked device types with 1,272 MAUDE reports spanning 1993–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →

Malfunction reports run above the device-type norm

Bed, Pediatric Open Hospital carries 94.0% MALFUNCTION-coded reports, 29.2pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.2% corpus 1.5% · below corpus mean (-1.3 pp)
  • INJ 2.8% corpus 30.3% · below corpus mean (-27.5 pp)
  • MALF 94.0% corpus 64.8% · above corpus mean (+29.2 pp)

Lead product-problem code Break is 27% of coded problems · Lead manufacturer STRYKER MEDICAL-KALAMAZOO accounts for 88% of manufacturer-tagged reports · Top event location is 52% of location-tagged rows .

Bed, Pediatric Open Hospital in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Bed, Pediatric Open Hospital carries 1,272 MAUDE reports, ranked #610 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Malfunction 1,196 (94.0%)
Injury 36 (2.8%)
19 (1.5%)
Other 19 (1.5%)
Death 2 (0.2%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

1,222 (95.5%)
Other 25 (2.0%)
Hospitalization 7 (0.5%)
Required Intervention 7 (0.5%)
Life Threatening 5 (0.4%)
R 4 (0.3%)
S 3 (0.2%)
Disability 3 (0.2%)
Death 2 (0.2%)
L 1 (0.1%)

Top Product Problems

Break 356
Device Slipped 257
Device Operates Differently Than Expected 143
Positioning Failure 68
Sticking 66
Mechanical Problem 53
Device Fell 51
Detachment Of Device Component 42
Scratched Material 41
Incorrect Measurement 38
False Reading From Device Non-Compliance 35
Component Falling 31
Loose or Intermittent Connection 23
Unintended System Motion 21
Incorrect, Inadequate or Imprecise Result or Readings 18
Device Inoperable 17
Unintended Movement 17
Mechanical Jam 16
Mechanics Altered 16
Positioning Problem 16

Yearly Trend

93
1993: 1
94
1994: 3
95
1995: 2
96
1996: 3
97
1997: 2
98
1998: 4
99
1999: 3
00
2000: 2
02
2002: 2
03
2003: 6
04
2004: 3
05
2005: 9
06
2006: 5
07
2007: 7
08
2008: 2
09
2009: 7
10
2010: 20
11
2011: 67
12
2012: 80
13
2013: 136
14
2014: 157
15
2015: 175
16
2016: 137
17
2017: 121
18
2018: 113
19
2019: 30
20
2020: 28
21
2021: 28
22
2022: 22
23
2023: 29
24
2024: 30
25
2025: 26
26
2026: 12

Reports in 2025 (26) held close to the prior two-year average of 30.

Related Entities for Bed, Pediatric Open Hospital

Event Locations

665 (52.3%)
I 538 (42.3%)
HOSPITAL 42 (3.3%)
NO INFORMATION 11 (0.9%)
HOME 7 (0.6%)
INVALID DATA 4 (0.3%)
OTHER 3 (0.2%)
UNKNOWN 2 (0.2%)

Compare STRYKER MEDICAL-KALAMAZOO vs STRYKER MEDICAL →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Bed, Pediatric Open Hospital: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (1,272 here).

Similar death-typed counts

Nearest other device types by death-typed report count (2 here), distinct from the volume row.

Disclaimer: MAUDE figures for Bed, Pediatric Open Hospital are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.

Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for Bed, Pediatric Open Hospital; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.